Once again, the biopharmaceutical industry had another banner year in 2015. The FDA approved 45 new medicines last year, the most since 1996 when 53 new medical entities were given the green light. But, in comparing the approvals of 1996 to 2015, a lot has changed over the years. For one thing, the vast majority of drugs approved in 1996 were small molecule drugs, including one of the biggest-selling drugs of all time, Lipitor (atorvastatin). It is fascinating to note that only two biologicals appeared in 1996, the insulin analog, Humalog, and Avonex (interferon beta-1a). Furthermore, like Lipitor, most if not all of the drugs in the class of ’96 are now generic. It’s often good to keep that in mind as we review the class of ’15 as all new drugs have a finite life as a patented product for its manufacturer.
